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临床试验/NCT03928730
NCT03928730已完成不适用

Assessment of Ultrasonographic Examination for Maxillofacial Swellings

Tarek A Abdelsalam, MD2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
2
主要终点
Correlation between ultrasonographic features and swellings types

研究概览

简要总结

Fifty patients were randomly selected with oral and/or maxillofacial swelling, thorough case history and clinical examination were done, then ultrasound examinations were done for all of them and they were classified into five groups (I. inflammatory/space infection and abscess swellings), (II. cystic swellings), (III. lymph node swellings), (IV. benign swellings) and (V. malignant neoplastic swellings) according to their ultrasound features. The patients were subjected to histopathologic evaluation.

详细描述

Fifty patients with swellings in the oral and/or maxillofacial region were randomly selected. Any other swellings that were caused by trauma and/or fracture, extended below the neck or patient reluctant to undergo US were excluded from the study. This study was approved by the (Research Ethics Committee) (REC), Faculty of Dentistry, Minia University before starting the research and all the entire patients had signed a standardized informed consent laid down by REC.

A comprehensive questionnaire was used to assess history and through extra-oral & intra-oral examinations were carried out and recorded on the basis of criteria reported by Das.11 The ultrasonographic investigations were carried using an ultrasound diagnostic modality (LOGIQ- P5) (GE Medical System, Korea) with color Doppler function by using a linear array transducer, operating at a frequency of (7.5-12 MHz). All the examinations were performed over the swellings and also compared to the contra-lateral/normal side whenever needed. (Fig. 1) All sonographic images were interpreted by an expert sonologist (15 years experience) and US features were recorded to extract ultrasonographic guided (USG) diagnosis and patient's swellings were categorized into five groups: inflammatory/infection/abscess swellings (Group I), cystic swellings (Group II), lymph node swellings (Group III), benign swellings (Group IV) and malignant neoplastic swellings (Group V).12 Finally, the included patients were subjected to either fine needle aspiration cytology (FNAC) or surgical intervention for histopathological examination to extract the histopathological diagnosis

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Diagnostic
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • All with oral and/or maxillofacial swelling,

排除标准

  • Any other swellings that were caused by trauma and/or fracture, extended below the neck or patient reluctant to undergo US were excluded from the study.

结局指标

主要结局

Correlation between ultrasonographic features and swellings types

时间窗: 2 months

Correlation between ultrasonographic features and swellings types

次要结局

未报告次要终点

研究者

发起方
Tarek A Abdelsalam, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Tarek A Abdelsalam, MD

Dentist

Minia University

研究点 (2)

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